Страна: Израел
Език: английски
Източник: Ministry of Health
DYDROGESTERONE
ABBOTT MEDICAL LABORATORIES LTD, ISRAEL
G03DB01
FILM COATED TABLETS
DYDROGESTERONE 10 MG
PER OS
Required
ABBOTT HEALTHCARE PRODUCTS B.V., NETHERLANDS
DYDROGESTERONE
DYDROGESTERONE
Cases where progesterone supplement is needed.
2023-10-31
1 DUPHASTON FILM COATED TABLETS 1. NAME OF THE MEDICINAL PRODUCT Duphaston 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg dydrogesterone. Excipient with known effect: 111.1 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM A round, biconvex, white film-coated tablet, (with a diameter of 7 mm) with a score line, with the inscription ‘155’ on both sides of the score line. The score line is only to make the tablet easier to break so that it is easier to swallow; it is not intended for dividing it into equal doses. 4. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS 4.1 Cases where progesterone supplement is needed. POSOLOGY AND METHOD OF ADMINISTRATION 4.2 Posology The following dosage regimens are recommended for treatment with Duphaston. The quantities can be adjusted according to the seriousness of the disorder to be treated and the individual patients’ responses to the treatment. _Regulation of the cycle _ It is possible to achieve a cycle lasting 28 days by giving 1 tablet of Duphaston a day from the 11 th to the 25 th day of the cycle. _Endometriosis _ 1 to 3 tablets of Duphaston a day from the 5 th to the 25 th day of the cycle or for the entire cycle. Dosages of 10 mg several times a day should be spread over the day. It is recommended to start treatment with the highest dosage. _ _ _Dysmenorrhoea _ 1 to 2 tablets of Duphaston a day from the 5 th to the 25 th day of the cycle. Dosages of 10 mg several times a day should be spread over the day. It is recommended to start the treatment with the highest dosage. _Infertility as a result of corpus luteum insufficiency _ 1 tablet of Duphaston a day from the 14 th to the 25 th day of the cycle. 2 Treatment should be continued for at least 6 consecutive cycles. It is advisable to continue this treatment for the first months of any pregnancy at dosages as indicated for habitual abortion. _Luteal support as part of an Assisted Reproductive Technology (ART) treatment _ 1 tablet of Duph Прочетете целия документ